Sample Collection for Evaluation of the Panbio™ COVID-19/ Flu A&B Rapid Panel.

COVID-19, Influenza A, Influenza Type B

This study is designed as a prospective, multicentric, sample collection study. The collected samples will be used for diagnostic research, product development and validation of the Panbio™ COVID-19/ Flu A&B Rapid Panel for the qualitative detection of COVID-19 antigen, Influenza A antigen (H1N1 and H3N2), and Influenza B antigen in human nasal and nasopharyngeal swabs by the study sponsor, Abbott.

A minimum of 665 male and female Subjects will be prospectively enrolled at multiple clinical sites. A minimum of 90 Flu A reference positive subjects, a minimum of 90 Flu B reference positive subjects and a minimum of 100 SARS-CoV-2 reference positive subjects will be enrolled. In addition, a minimum of 385 reference-negative subjects will be enrolled. In order to meet these minimum numbers it is anticipated that approximately 2000 subjects will be enrolled in total. Subjects should be enrolled from point of care for this study. After informed consent has been obtained, operators will collect one nasal swab from both nostrils from each Subject. Every second subject will be asked to blow their nose first and this will be recorded. Collection procedure will be a mid-turbinate nasal swab (deep nasal swab), by turning the swab five times in each nostril. The collected swab will be returned to a plastic tube (provided by the sponsor) and immediately (or within 15 minutes of collection) stored frozen at -80°C (or -20°C if -80°C storage is not available) for later testing with the Panbio™ Rapid Panel. Touching of the tube wall with the swab should be avoided. Nasal samples must be collected prior to the Nasopharyngeal sampling. After the nasal sampling, the operators will collect a nasopharyngeal swab from one nostril of each subject. The NP swab will be returned to a plastic tube (provided by the sponsor) by study staff (touching the tube walls should be avoided) and immediately (or within 15 minutes of collection) stored frozen at -80°C (or -20°C if -80°C storage is not available) for later testing with the Panbio™ Rapid Panel. A second nasopharyngeal swab, collected from the other nostril of each subject will be eluted in Universal Transport Media (UTM) and used for testing with RT-PCR protocols for Flu A, Flu B and SARS-CoV-2 as per local procedures. The remaining UTM will be labelled with Subject ID and immediately stored frozen at -80°C (or -20°C minimum). The RT-PCR methods used must have CE marking or FDA approval, with COVID-19 and Flu assay clearance for nasopharyngeal specimens and must be approved by the Sponsor. Nasopharyngeal sampling should be performed by trained healthcare professionals who routinely conduct nasopharyngeal sampling as part of their other standard of care and clinical duties. All other aspects of the Subject's care will remain the same with no deviation from prescribed practice. Each subject's demographic information, symptomology data, and professionally performed test result and questionnaire will be recorded on source documentation and transferred to an Electronic Data Capture system. Samples collected in this study will be used for diagnostic research, product development and validation of the Panbio™ COVID-19/ Flu A&B Rapid Panel by the study sponsor, Abbott.

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United States